The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF. The main questions it aims to answer are: Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure? Participants will: Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System. Have follow-up visits at 3, 6, and 12 months after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Pulsed field catheter ablation for pulmonary vain isolation.
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
West China Hospital Sichuan University
Chengdu, China
Guangdong Province People's Hospital
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
Jiangsu Province Hospital
Nanjing, China
Nanjing Drum Tower Hospital
Nanjing, China
Shanghai Jiao Tong University School of Medicine Ruijin Hospital
Shanghai, China
Chinese People's Liberation Army Northern Theater Command General Hospital
Shenyang, China
Tianjin Chest Hospital
Tianjin, China
The Fisrt Affliated Hopital of Xinjiang Medical Universtiy
Ürümqi, China
Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation
The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure.
Time frame: Through 6 months post-ablation
Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation
The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period.
Time frame: 12 months post-ablation
Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure
Change in AFEQT score from baseline to 12 months after the index ablation procedure. The AFEQT questionnaire assesses the impact of atrial fibrillation on a participant's quality of life. The overall score ranges from 0 to 100, with higher scores indicating better quality of life.
Time frame: Baseline through 12 months after the index ablation
Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure
Change in EQ-5D-5L composite score from baseline to 12 months after the index ablation procedure. The EQ-5D-5L Questionnaire is a standardized instrument for measuring health status. The Chinese EQ-5D-5L value set will be used to calculate the composite score. The composite score ranges from -0.391 to 1, with higher scores indicating better health status.
Time frame: Baseline through 12 months after the index ablation procedure
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